Trial Outcomes & Findings for Laboratory-Treated T Cells in Treating Patients With High-Risk Relapsed Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia Previously Treated With Donor Stem Cell Transplant (NCT NCT01640301)

Last Updated: 2022-07-14

Results Overview

Response is assessed throughout the 1 year post treatment timeframe. Morphologic criteria for response: Complete Response (CR) = Bone Marrow blasts \<5%; no blasts with Auer rods; no extramedullary disease. Transfusion independent. Platelets ≥ 100,000/μl Absolute neutrophil count \>1000/μl (CRi: incomplete hematologic recovery CRp: incomplete platelet recovery) Partial Response (PR) = Decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow and the normalization of blood counts as for CR. (PRi and PRp if incomplete hematologic or platelet recovery) Stable Disease (SD) = Failure to achieve at least PR, but no evidence of progression for \>4 weeks.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

47 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2022-07-14

Participant Flow

47 participants were enrolled on the study, meaning they signed the consent for treatment. However, 19 did not move on to treatment for various reasons.

Participant milestones

Participant milestones
Measure	Arm I (High-risk for Relapse After HCT) Patients with no evidence of leukemia or MDS post-HCT receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 14 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV	Arm II (Relapsed After HCT) Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
Overall Study STARTED	13	15
Overall Study COMPLETED	13	7
Overall Study NOT COMPLETED	0	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (High-risk for Relapse After HCT) Patients with no evidence of leukemia or MDS post-HCT receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 14 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV	Arm II (Relapsed After HCT) Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
Overall Study Death	0	8

Baseline Characteristics

Laboratory-Treated T Cells in Treating Patients With High-Risk Relapsed Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia Previously Treated With Donor Stem Cell Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (High-risk for Relapse After HCT) n=13 Participants Patients with no evidence of leukemia or MDS post-HCT receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 14 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV	Arm II (Relapsed After HCT) n=15 Participants Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	15 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: 4 patients in Arm II did not relapse and were not assessed. 1 pt progressed at their D365 visit timepoint which landed on D367. They were included in the count of participants that passed within their 1 year follow-up timeframe.

Outcome measures

Outcome measures
Measure	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=9 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.	Arm II (Relapsed After HCT) Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
Anti-leukemic Potential Efficacy, in Terms of Duration of Response (Arm II)	28 days Interval 5.0 to 367.0	—

PRIMARY outcome

Timeframe: At 1 year post-transplant

Population: No patients in Arm I relapsed, so overall number of participants analyzed is 0

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 1 year

Outcome measures

Outcome measures
Measure	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=12 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.	Arm II (Relapsed After HCT) Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
Count of Participants Who Experienced Chronic Graft Versus Host Disease (GVHD) (Arm I)	6 Participants	—

PRIMARY outcome

Timeframe: Up to 1 year

Outcome measures

Outcome measures
Measure	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=15 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.	Arm II (Relapsed After HCT) Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
Count of Participants Who Experienced Chronic Graft Versus Host Disease (GVHD) (Arm II)	8 Participants	—

PRIMARY outcome

Timeframe: Up to 1 year following infusion per patient

Population: 2 patients were unevaluable for this outcome due to old documentation, unable to discern if the patient had acute GvHD greater than or equal to grade 3.

Outcome measures

Outcome measures
Measure	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=13 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.	Arm II (Relapsed After HCT) Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
Count of Participants Who Experienced Grade III-IV Acute Graft Versus Host Disease (GVHD) (Arm II)	0 Participants	—

PRIMARY outcome

Timeframe: Up to 1 year

Population: All patients were evaluated for aGvHD greater than or equal to Grade 3

Outcome measures

Outcome measures
Measure	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=13 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.	Arm II (Relapsed After HCT) Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
Count of Participants Who Experienced Grade III-IV Acute Graft-versus-host Disease (GVHD) (Arm I)	1 Participants	—

PRIMARY outcome

Timeframe: Up to 30 days after last study intervention per patient

Outcome will be reported as a count of participants that experienced adverse events. Toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 4.0

Outcome measures

Outcome measures
Measure	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=13 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.	Arm II (Relapsed After HCT) Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
Treatment-related Toxicity Rate (Arm I)	12 Participants	—

PRIMARY outcome

Timeframe: Up to 30 days after last study intervention per patient

Outcome measures

Outcome measures
Measure	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=15 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.	Arm II (Relapsed After HCT) Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
Treatment-related Toxicity Rate (Arm II)	15 Participants	—

SECONDARY outcome

Timeframe: Up to 1 year

Outcome measures

Outcome measures
Measure	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=13 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.	Arm II (Relapsed After HCT) n=15 Participants Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
Disease-free Survival After T Cell Therapy	13 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Outcome measures

Outcome measures
Measure	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=15 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.	Arm II (Relapsed After HCT) Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
Incidence of Relapse After T Cell Therapy (Arm II)	9 Participants	—

SECONDARY outcome

Timeframe: Up to 28 days post intervention per patient

Outcome measures

Outcome measures
Measure	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=12 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.	Arm II (Relapsed After HCT) Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
Maintenance of T Cell Receptor (TCR) Expression of Transduced T Cells (Arm I) i.e. Persistence	12 Participants	—

SECONDARY outcome

Timeframe: Up to 28 days post intervention per patient

Outcome measures

Outcome measures
Measure	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=12 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.	Arm II (Relapsed After HCT) Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
Maintenance of Function of Transduced T Cells (Arm I)	9 Participants	—

SECONDARY outcome

Timeframe: Up to 1 year

Population: No patients analyzed because no patients relapsed in Arm I

Outcome measures

Outcome data not reported

Adverse Events

Arm I (High-risk for Relapse After HCT)

Serious events: 5 serious events

Other events: 12 other events

Deaths: 0 deaths

Arm II (Relapsed After HCT)

Serious events: 5 serious events

Other events: 15 other events

Deaths: 8 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Aude Chapuis

Fred Hutchinson Cancer Research Center

Phone: 2066674369

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm I (High-risk for Relapse After HCT) n=13 participants at risk Patients with no evidence of leukemia or MDS post-HCT receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 14 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV	Arm II (Relapsed After HCT) n=15 participants at risk Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Cardiac disorders Pericardial Effusion	7.7% 1/13 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/15 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Gastrointestinal disorders Duodenal obstruction	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
General disorders Multi-organ failure	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
General disorders Fever	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Infections and infestations Appendicitis	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Infections and infestations Wound infection	7.7% 1/13 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/15 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Infections and infestations Lung Infection	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Injury, poisoning and procedural complications Fall	15.4% 2/13 • Number of events 2 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/15 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Investigations CPK Increased	7.7% 1/13 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/15 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Metabolism and nutrition disorders Hypercalcemia	7.7% 1/13 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/15 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Renal and urinary disorders Acute kidney injury	15.4% 2/13 • Number of events 2 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/15 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Skin and subcutaneous tissue disorders Skin Sclerosis	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Vascular disorders Superior vena cava syndrome	7.7% 1/13 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/15 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.

Measure	Arm I (High-risk for Relapse After HCT) n=13 participants at risk Patients with no evidence of leukemia or MDS post-HCT receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 14 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV	Arm II (Relapsed After HCT) n=15 participants at risk Patients with evidence of AML (minimal residual disease or overt relapse) post-HCT receive cyclophosphamide IV and fludarabine phosphate IV daily on days -4 to -2. Patients also receive WT1-sensitized T cells IV over 45 minutes (or longer for patients who are 15-30 kg) on days 0 and 21 and aldesleukin SC BID on days 14-28. Aldesleukin: Given SC Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies WT1-Sensitized Allogeneic T-Lymphocytes: Given IV
Blood and lymphatic system disorders Anemia	30.8% 4/13 • Number of events 16 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	53.3% 8/15 • Number of events 18 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Cardiac disorders Sinus tachycardia	7.7% 1/13 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Gastrointestinal disorders Abdominal pain	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Gastrointestinal disorders Diarrhea	7.7% 1/13 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Gastrointestinal disorders Dry mouth	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Gastrointestinal disorders Mucositis oral	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	13.3% 2/15 • Number of events 2 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Gastrointestinal disorders Nausea	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	13.3% 2/15 • Number of events 2 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Gastrointestinal disorders Rectal pain	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
General disorders Chills	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
General disorders Fatigue	7.7% 1/13 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	13.3% 2/15 • Number of events 2 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
General disorders Fever	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Immune system disorders Cytokine release syndrome	7.7% 1/13 • Number of events 2 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/15 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Infections and infestations CANDIDA KRUSEI	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Infections and infestations Catheter related infection	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Infections and infestations Device related infection	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Infections and infestations Lung infection	7.7% 1/13 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/15 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Infections and infestations Sinusitis	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Infections and infestations Urinary tract infection	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Investigations Alanine aminotransferase increased	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Investigations Aspartate aminotransferase increased	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Investigations CD4 lymphocytes decreased	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Investigations Lymphocyte count decreased	53.8% 7/13 • Number of events 13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	53.3% 8/15 • Number of events 15 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Investigations Neutrophil count decreased	15.4% 2/13 • Number of events 2 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	80.0% 12/15 • Number of events 20 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Investigations Platelet count decreased	15.4% 2/13 • Number of events 2 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	80.0% 12/15 • Number of events 20 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Investigations White blood cell decreased	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	53.3% 8/15 • Number of events 13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Metabolism and nutrition disorders Anorexia	7.7% 1/13 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	13.3% 2/15 • Number of events 7 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Metabolism and nutrition disorders Hyperkalemia	7.7% 1/13 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/15 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	13.3% 2/15 • Number of events 2 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	20.0% 3/15 • Number of events 3 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Metabolism and nutrition disorders Hyponatremia	15.4% 2/13 • Number of events 2 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	33.3% 5/15 • Number of events 10 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	26.7% 4/15 • Number of events 5 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Musculoskeletal and connective tissue disorders Myalgia	7.7% 1/13 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/15 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF THE SKIN	7.7% 1/13 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/15 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Nervous system disorders Dizziness	15.4% 2/13 • Number of events 2 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/15 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Renal and urinary disorders Chronic kidney disease	7.7% 1/13 • Number of events 5 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Renal and urinary disorders Proteinuria	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.7% 1/13 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/15 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Skin and subcutaneous tissue disorders Rash maculo-papular	7.7% 1/13 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	20.0% 3/15 • Number of events 4 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Vascular disorders Hypertension	23.1% 3/13 • Number of events 5 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	13.3% 2/15 • Number of events 2 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Vascular disorders Hypotension	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	20.0% 3/15 • Number of events 3 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Vascular disorders Thromboembolic event	0.00% 0/13 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	6.7% 1/15 • Number of events 1 • Up to 1 year post infusion per patient Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.